Government website best place for clinical trial info

DEAR DR. ROACH: My wife has had dementia for over two years. There is an ad in our local paper for an Alzheimer’s disease study. It says, “This study will assess how safe and effective an investigational drug is at slowing the progression of early (prodromal) or mild Alzheimer’s disease.” Is this protocol legit? I don’t trust this type of ad not coming from a hospital. I couldn’t find any information about the sponsors of the research. — J.N.

ANSWER: I was able to find the trial, called the Graduate II trial, which is sponsored by the manufacturer of the drug being tested, called gantenerumab. This drug is designed to reduce the size of the amyloid protein plaques in the brain, which are suspected of being the underlying cause of Alzheimer’s disease, and to prevent new ones from forming. It is indeed a legitimate trial. The best place to find out about these is on the clinicaltrials.gov website. The trial is in phase III. The drug has passed both phase I trials, which are designed to look at safety, and phase II, which look at both safety and effectiveness. Now the investigators are studying the effectiveness of the drug in a larger population, usually for a longer period of time. Drugs that do well in phase III clinical trials may be approved by the Food and Drug Administration. Alzheimer’s drug trials are difficult, because the disease often progresses slowly, and large, time-consuming trials are necessary. In general, I encourage people to consider participating in clinical trials, as they are essential for clinical advances. For gantenerumab in particular, phase I and II trials did show that the drug is effective at reducing the amount of amyloid plaque in the brain; however, clinical trials did not show improvement in memory and brain function. The new trial is using a higher dose and recruiting patients with earlier stage illness.

I don’t have enough information to answer whether your wife, having had symptoms for two years, might be eligible for this trial, but I would certainly encourage you to find out more about it. *** Dr. Roach regrets that he is unable to answer individual letters, but will incorporate them in the column whenever possible. Readers may email questions to ToYour-GoodHealth@med.cornell. edu or send mail to 628 Virginia Dr., Orlando, FL 32803.